35mm Block / Spacer

GUDID 00810028397170

Medshape, Inc.

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID00810028397170
NIH Device Record Key07ca37dd-e30a-41b5-8da7-8ac4cd05805e
Commercial Distribution StatusIn Commercial Distribution
Brand Name35mm Block / Spacer
Version Model NumberDNE-6000-350
Company DUNS601306413
Company NameMedshape, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810028397170 [Primary]

FDA Product Code

KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


[00810028397170]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-10
Device Publish Date2024-05-31

On-Brand Devices [35mm Block / Spacer]

00810028397170DNE-6000-350
00810028396289DNE-6000-350

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